Clinical Trial Research Nurse

Overview

We are currently searching for a Clinical Trials Research Nurse to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD

Duties & Responsibilities

• Oversee all aspects of participant study outpatient visits and inpatient admissions.
• Communicate with potential participants and screen for eligibility for study.
• Obtain and review potential participant medical records and history to determine eligibility.
• Schedule participant visits and coordinate travel and housing for participants.
• Coordinate participant schedule, consultations, and imaging appointments.
• Ensure safe handling of various specimens in accordance with prescribed protocols.
• Review patient care policies and procedures utilizing NIH guidelines as it relates to patient admissions.
• Maintain appropriate research records in CRIS.
• Consent and maintain research documents for participants.
• Coordinate recruitment, consent, and specimens for mail-in biologic specimens.
• Communicate and collaborate with the Principal Investigator and multidisciplinary research team to ensure that patient management strategies are successful in meeting patient care and research needs.
• Communicate with participants, their caregivers, and physicians regarding appointments, laboratory findings, and imaging results, and management plan as needed.
• Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
• Contribute to the design, methodology, implementation, and regulatory review of specific protocols as assigned.
• Coordinate multi-site IRB protocol in which NIH is the IRB of record including maintaining participant logs in coordination with other sites.
• Coordinate single-site IRB protocols at NIH.
• Assure that all procedures are being carried out per protocol.
• Collect and ensure that sample volumes collected are within protocol limits.
• Observe and ensure the safety of human subjects while procedures are being performed.
• Create participant logs and monthly and annual reports for open studies.
• Manage IRB review cycle submissions, including initial review, continuing review, amendments, and reports in accordance with IRB, NIH and other applicable regulations.
• Contribute to the design, methodology, implementation, and regulatory review of research protocols, including informed consents, manual of operating procedures, and SOP's.
• Understand Good Clinical Practices and federal human subjects research regulatory requirements and ensure compliance of research protocols with relevant requirements.
• Coordinate with the IRB, Office of Human Research Protection, and other regulatory authorities at NIH and other sites as needed.
• Respond to inquiries and audits from regulatory agencies, including researching the issues, assembling documentation, and preparing written responses.
• Train staff and site investigators on regulatory requirements, including but not limited to IRB processes, informed consent, and adverse event reporting.
• Survey the medical literature for background information on specific aspects of the diseases under purview.
• Organize research information for clinical projects.
• Create and review sample submission forms for accuracy prior to database entry.
• Create and maintain database of clinical information for use in clinical research studies.
• Create data collection forms for research studies and collect relevant data.
• Provide a detail-oriented approach, able to work independently and efficiently to track multiple deadlines and keep projects on target and moving forward.
• Anticipate and identify problems, consider alternatives, and work collaboratively and creatively to solve problems.

Requirements

• A Degree from a professional nursing program approved by the legally designated State accrediting agency at the time the program was completed by the applicant.
• Current licensure to practice as a nurse in the state of Maryland.
• Minimum of four (4) years of education, training, and experience equivalent to a Registered Nurse/masters level to advise and serve as an authority and consultant Investigators.
• Knowledge of the Good Clinical Practice guidelines, Institutional Review Board guidelines, and the NIH standards for Clinical Research Practice is highly desired.
• Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.
• Ability to effectively communicate, both verbally and in writing, including advanced interpersonal communication skills, presentation skills, and professional writing skills.
• Ability to use information technology associated with patient care and research information management.

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Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...

• Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
• Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
• Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
• Discovery! With our tuition assistance and training programs, we support your career advancement.
• Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
• Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
• Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
• A Voice! A unique culture where you can influence decisions and have your voice heard.

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.